DepressionHERDANCT07915427
HERDA: Pharmacist-Led Culturally Adapted Intervention for Depression Medication Adherence
A study testing HERDA Pharmacist-Led Culturally Adapted Intervention in people with Depression, run by Gadjah Mada University at 1 site in Indonesia.
Trial summary
HERDA (Holistic, Evidence-based, and cultuRally adapted Depression Adherence) is a pharmacist-led intervention developed to support medication adherence among outpatients with depression in South Kalimantan, Indonesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- HERDA Pharmacist-Led Culturally Adapted Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteIndonesia
- Study dates
- 18 Aug 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older.
- A clinical diagnosis of depressive disorder based on DSM-5 criteria, as documented in the medical record.
- Currently prescribed oral antidepressant medication.
- Able to understand study information and communicate in Bahasa Indonesia or Banjar.
- Able to use an Android mobile phone.
- Willing and able to participate in study procedures and provide written informed consent.
Who cannot join
- Organic brain disorders or intellectual disabilities that impair the ability to understand study information, provide informed consent, or participate in study procedures.
- Severe comorbid conditions that may interfere with safe participation, including psychotic disorders, substance addiction, severe stroke, severe heart disease, severe diabetes-related complications, or other severe chronic conditions deemed unsuitable for participation by the treating physician.
- Inability to understand the study materials or hearing impairment that prevents effective communication or completion of study assessments.
- Any other condition that, according to the study protocol and clinical assessment, prevents safe participation in the intervention or completion of outcome assessments.
- Eligible outpatients will be screened before enrollment. Written informed consent will be obtained before any study-specific procedures are performed.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Rumah Sakit Jiwa Sambang Lihum
Gambut, South Kalimantan, 70652
About this study
Official title: A Randomized Controlled Trial of HERDA: A Culturally Adapted Pharmacist-Led Intervention to Improve Medication Adherence in Outpatients With Depression
HERDA (Holistic, Evidence-based, and cultuRally adapted Depression Adherence) is a pharmacist-led intervention developed to support medication adherence among outpatients with depression in South Kalimantan, Indonesia. It combines structured counseling, behavior change strategies, pharmaceutical care, and culturally adapted educational materials to help patients identify and address difficulties in taking their prescribed medication.
The intervention incorporates the 5A Brief Counseling framework and the Transtheoretical Model (TTM), which guides counseling according to each participant's readiness to change. It also includes screening and a predefined safety pathway for suicide-related concerns, culturally adapted psychoeducation, and family or caregiver engagement when appropriate and with the participant's consent. Cultural, spiritual, and existential considerations are addressed according to individual preferences and within predefined intervention guidelines.
Read more
HERDA is delivered by trained pharmacists alongside standard psychiatric care. Participants assigned to the intervention group receive seven planned contacts over approximately four months, combining face-to-face sessions and telephone contacts. Participants assigned to the control group receive standard psychiatric care according to the study protocol.
This randomized controlled trial evaluates whether adding HERDA to standard psychiatric care improves medication adherence among outpatients with depression. The findings are intended to inform the development of evidence-based, culturally responsive pharmacist-led care for people receiving treatment for depression.
Read the detailed description
HERDA (Holistic, Evidence-based, and cultuRally adapted Depression Adherence) is a pharmacist-led, complex intervention developed to address medication non-adherence among outpatients with depression in South Kalimantan, Indonesia.
The intervention is delivered by trained pharmacists who complete competency assessment before providing HERDA. Counseling is tailored to each participant's current TTM stage. Each intervention contact follows a structured sequence comprising assessment, identification or reassessment of the TTM stage, Brief Counseling 5A, stage-matched education, appropriate use of intervention materials, collaborative action planning, family or caregiver involvement when appropriate and with participant consent, and follow-up or reassessment.
Educational content may be repeated or adjusted according to participants' needs and changes in their stage of behavioral change. Such tailoring is conducted within predefined adaptation boundaries to preserve the intervention's core clinical components and support consistency across participants.
Participants assigned to the intervention arm receive seven planned contacts over approximately four months. Face-to-face contacts occur at Visits 1, 3, 5, and 7, while telephone contacts occur at Visits 2, 4, and 6.
Visit 1 includes the baseline assessment and initial intervention contact, as specified in the study protocol. Visit 7 includes the final post-intervention assessment and the planned final intervention contact. HERDA is delivered alongside standard psychiatric care, which continues throughout the study period. The control group receives standard psychiatric care according to the study protocol.
HERDA uses culturally adapted educational materials, including Banjar-language audiovisual education and electronic flipbooks.
Intervention fidelity will be monitored throughout the HERDA intervention period as part of study quality assurance. Before intervention delivery, pharmacist counselors will undergo training and simulation to support standardized intervention delivery. Standardized pharmacist session logbooks, session checklists, supervision, and random internal audits will be used to document and monitor intervention implementation. Recorded indicators will include completion of scheduled intervention contacts, counseling duration, adherence to the HERDA protocol, delivery of applicable core counseling components, appropriate use of the Clinical Decision Matrix and Transtheoretical Model (TTM), use of educational materials when indicated, action planning, follow-up arrangements, patient understanding of key counseling messages, and session documentation.
Each applicable intervention component will be classified as delivered according to protocol, partially delivered, not delivered according to protocol, or not applicable. Safety-protocol compliance, protocol deviations, reasons for incomplete or modified sessions, and corrective actions, where applicable, will be documented separately. Periodic supervision and refresher training will be provided when needed to support consistent intervention delivery. Process evaluation data will be summarized descriptively to characterize intervention delivery and implementation throughout the study period. These monitoring procedures are intended to assess intervention implementation and are not measures of patient medication adherence or evidence of medication ingestion.
As a supplementary process evaluation, the acceptability and implementation of HERDA will also be explored after completion of the intervention through focus group discussions (FGDs) with pharmacist counselors, in-depth interviews with patients and family members, and a satisfaction questionnaire, as specified in the study procedures. Evaluation domains will include perceived benefits, satisfaction, experiences of receiving or delivering the intervention, implementation challenges, and recommendations for improvement. Qualitative data will be analyzed thematically, while questionnaire findings will be summarized descriptively. These findings will be used to characterize intervention acceptability and implementation and to inform interpretation of the study findings. They will be analyzed and interpreted separately from the randomized comparison of clinical and behavioral outcomes and will not constitute formal trial outcome measures.
This randomized controlled trial evaluates whether adding the HERDA pharmacist-led, culturally adapted intervention to standard psychiatric care improves medication adherence among outpatients with depression compared with standard psychiatric care alone. The study is intended to contribute evidence on the implementation of structured, culturally responsive pharmaceutical care for people receiving treatment for depression in Indonesia.
- Conditions
- Depression
- Being tested
- HERDA Pharmacist-Led Culturally Adapted Intervention
- Keywords
- Medication Adherence, HERDA, Pharmacist-Led Intervention, Culturally Adapted Intervention, Antidepressants, Pharmaceutical Care, Transtheoretical Model, Brief Counseling
- Medical subject headings
- Depression, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HERDA Pharmacist-Led Culturally Adapted InterventionBehavioural
HERDA is a structured pharmacist-led, culturally adapted behavioral intervention designed to improve medication adherence among outpatients with depression. It integrates Brief Counseling 5A, the Transtheoretical Model (TTM) to tailor counseling to participants' readiness to change, pharmaceutical care, culturally adapted psychoeducation, and a predefined safety pathway for suicide-related concerns. The intervention is delivered by trained pharmacists through seven planned contacts over approximately four months, comprising face-to-face sessions and telephone contacts. Educational materials include Banjar-language audiovisual content and electronic flipbooks. Family or caregiver engagement is included when appropriate and with participant consent. HERDA is delivered in addition to standard psychiatric care and does not replace prescribed treatment or clinical assessment.
| Study group | Role | What they receive |
|---|---|---|
| HERDA Intervention Group | Experimental | Participants receive the HERDA pharmacist-led, culturally adapted intervention in addition to standard psychiatric care. The intervention consists of seven planned contacts over approximately four months, combining face-to-face sessions and telephone contacts, delivered by trained pharmacists according to the study protocol. Receives: Behavioral: HERDA Pharmacist-Led Culturally Adapted Intervention |
| Usual Care Group | No intervention | Participants receive standard psychiatric care according to the study protocol, without the additional HERDA pharmacist-led intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Adherence Measured by MARS-5
Medication adherence to antidepressants will be assessed using the five-item Medication Adherence Rating Scale (MARS-5). Each item is scored from 1 (always) to 5 (never), with higher scores indicating better adherence. The total score is the sum of all five items, ranging from 5 to 25. Adherence will be classified as adherent (total score ≥23; coded as 2) or non-adherent (total score <23; coded as 1), according to the study's prespecified operational definition.
Measured: Day 0 (baseline), Day 30, Day 60, and Day 120.
Medication Adherence Measured by Pill Count
Medication adherence to antidepressants will be assessed by pill count. Adherence (%) will be calculated as [(tablets available for use during the assessment interval - tablets remaining at the end of the interval) / (prescribed tablets per day × number of days in the interval)] × 100%. Participants will be classified as adherent (80%-100%; coded 2) or non-adherent (<80%; coded 1), according to the study's prespecified criteria. Baseline pill count at V1 (Day 0) will document the initial medication supply. Adherence will be assessed over intervals ending at V3 (Day 30), V5 (Day 60), and V7 (Day 120). Dispensing records, early refills, and carryover tablets will be reconciled to account for available medication and prevent double-counting.
Measured: Day 0 (baseline), Day 30, Day 60, and Day 120.
Secondary outcomes (4)
Depressive Symptom Severity Measured by PHQ-9
Depressive symptom severity will be assessed using the nine-item Patient Health Questionnaire (PHQ-9), which evaluates the frequency of nine depressive symptoms over the preceding two weeks, including loss of interest or pleasure, depressed mood, sleep disturbances, fatigue, appetite changes, feelings of worthlessness or guilt, concentration difficulties, psychomotor changes, and thoughts of death or self-harm. Each item is scored from 0 (not at all) to 3 (nearly every day), yielding a total score ranging from 0 to 27, with higher scores indicating greater depressive symptom severity. Scores will be interpreted as minimal or no depressive symptoms (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20-27). The PHQ-9 will be administered at Visit 1 (T0, Day 0) and Visit 7 (T4, Day 120).
Measured: Day 0 (baseline) and Day 120.
Self-Stigma Measured by the Self-Stigma Scale-Short (SSS-S)
Self-stigma among patients with depression will be assessed using the nine-item Self-Stigma Scale-Short (SSS-S), as described by Wu et al. (2015). Each item is rated on a four-point Likert scale: 1 = strongly disagree, 2 = disagree, 3 = agree, and 4 = strongly agree. The total score ranges from 9 to 36, with higher scores indicating greater levels of self-stigma. Based on the study's prespecified classification, total scores will be categorized as minimal (9-15), mild (16-22), moderate (23-29), or severe (30-36). The SSS-S will be administered at Visit 1 (T0, Day 0) and Visit 7 (T4, Day 120) to assess self-stigma at baseline and at the end of the intervention period.
Measured: Day 0 (baseline) and Day 120.
Suicide Risk Assessed Using the MINI ICD-10 Suicidality Module
Suicide risk will be assessed using the six-item MINI ICD-10 suicidality module at V1 (T0, Day 0) and V7 (T4, Day 120). Responses will be classified as low, moderate, or high risk according to the instrument's algorithm. The HERDA Suicide Reflex Pathway will be activated for any safety concern. Moderate or high risk and acute concerns will prompt immediate clinical escalation. Participants with acute concerns will not be left alone while urgent evaluation is arranged. Referrals, safety planning, handover, and follow-up will be documented. Pharmacists will facilitate escalation, while clinical risk management remains the responsibility of qualified healthcare professionals.
Measured: Day 0 (baseline) and Day 120.
Medication-Related Health Behavior
Depression treatment-related knowledge, beliefs, and behaviors will be assessed using a study-specific 12-item questionnaire comprising three domains: cognitive (knowledge of depression, antidepressant treatment, risk factors, and lifestyle-related factors); affective (beliefs, attitudes, and willingness regarding antidepressant use and smoking-related risks); and behavioral (medication-carrying practices, dietary and smoking-related behavior, physical activity, and intention to discontinue antidepressants when symptoms improve). Each item will be scored as correct (+1) or incorrect (0) according to a predefined answer key, with negatively worded items scored accordingly. Domain-level findings and behavioral readiness will be interpreted according to the study's prespecified scoring criteria and Transtheoretical Model-based operational definitions. The questionnaire will be administered at V1 (T0, Day 0), V3 (T1, Day 30), V5 (T2, Day 60), and V7 (T4, Day 120).
Measured: Day 0 (baseline), Day 30, Day 60, and Day 120.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start18 Aug 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a two-arm, parallel-group randomized controlled trial involving 72 adult outpatients with depressive disorders at RSJ Sambang Lihum, Indonesia. Participants are randomized 1:1, stratified by depression severity and sex, to receive either HERDA plus usual psychiatric care or usual psychiatric care alone. HERDA is a pharmacist-led, culturally adapted intervention delivered through seven face-to-face and telephone contacts over four months. Outcomes are assessed at baseline and scheduled follow-up visits. Outcome assessors are blinded to group allocation, whereas intervention pharmacists are unblinded.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gadjah Mada University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chairun Wiedyaningsih, Gadjah Mada University
- Investigators
- Chairun Wiedyaningsih, Principal investigator, Gadjah Mada University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07915427
- Sponsor's protocol ID
- HERDA-RCT-2026
- Other IDs
- 196/KPA/C3/KPT/2026, 225/C3/DT.05.00/PLBARU/2026
- Acronym
- HERDA
- Status last verified
- Oct 2026
- First submitted
- 17 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision regarding individual participant data (IPD) sharing has not yet been finalized. This study collects sensitive information on depression, antidepressant medication adherence, self-stigma, and suicide risk. The feasibility of sharing de-identified IPD will be reviewed after considering the research ethics approval, informed consent provisions, applicable data protection requirements, and institutional policies. Any future data-sharing plan will specify the data to be shared, access criteria, timing, and procedures for protecting participant confidentiality. No commitment to share IPD has been made at this stage.
Publications
Ariyani H, Wiedyaningsih C, Prabandari YS. Pharmacists' roles and barriers in supporting psychiatric medication adherence: An interprofessional qualitative study. Pharmacy Practice. 2026;24(2):1-21.
Ariyani H, Wiedyaningsih C, Prabandari RAYS, Idaiani S. Pharmacist intervention to improve medication adherence in patients with depressive disorder: A scoping review. Pharmacia. 2026;73:e178613.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of HERDA: A Culturally Adapted Pharmacist-Led Intervention to Improve Medication Adherence in Outpatients With Depression
- ClinicalTrials.gov ID
- NCT07915427
- Acronym / sponsor ID
- HERDA / HERDA-RCT-2026
- Conditions
- Depression
- Keywords
- Medication Adherence, HERDA, Pharmacist-Led Intervention, Culturally Adapted Intervention, Antidepressants, Pharmaceutical Care, Transtheoretical Model, Brief Counseling
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Gadjah Mada UniversityUniversity, hospital or other
- Study start
- 18 Aug 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
HERDA (Holistic, Evidence-based, and cultuRally adapted Depression Adherence) is a pharmacist-led intervention developed to support medication adherence among outpatients with depression in South Kalimantan, Indonesia. It combines structured counseling, behavior change strategies, pharmaceutical care, and culturally adapted educational materials to help patients identify and address difficulties in taking their prescribed medication.
The intervention incorporates the 5A Brief Counseling framework and the Transtheoretical Model (TTM), which guides counseling according to each participant's readiness to change. It also includes screening and a predefined safety pathway for suicide-related concerns, culturally adapted psychoeducation, and family or caregiver engagement when appropriate and with the participant's consent. Cultural, spiritual, and existential considerations are addressed according to individual preferences and within predefined intervention guidelines.
HERDA is delivered by trained pharmacists alongside standard psychiatric care. Participants assigned to the intervention group receive seven planned contacts over approximately four months, combining face-to-face sessions and telephone contacts. Participants assigned to the control group receive standard psychiatric care according to the study protocol.
This randomized controlled trial evaluates whether adding HERDA to standard psychiatric care improves medication adherence among outpatients with depression. The findings are intended to inform the development of evidence-based, culturally responsive pharmacist-led care for people receiving treatment for depression.
Detailed description
HERDA (Holistic, Evidence-based, and cultuRally adapted Depression Adherence) is a pharmacist-led, complex intervention developed to address medication non-adherence among outpatients with depression in South Kalimantan, Indonesia.
The intervention is delivered by trained pharmacists who complete competency assessment before providing HERDA. Counseling is tailored to each participant's current TTM stage. Each intervention contact follows a structured sequence comprising assessment, identification or reassessment of the TTM stage, Brief Counseling 5A, stage-matched education, appropriate use of intervention materials, collaborative action planning, family or caregiver involvement when appropriate and with participant consent, and follow-up or reassessment.
Educational content may be repeated or adjusted according to participants' needs and changes in their stage of behavioral change. Such tailoring is conducted within predefined adaptation boundaries to preserve the intervention's core clinical components and support consistency across participants.
Participants assigned to the intervention arm receive seven planned contacts over approximately four months. Face-to-face contacts occur at Visits 1, 3, 5, and 7, while telephone contacts occur at Visits 2, 4, and 6.
Visit 1 includes the baseline assessment and initial intervention contact, as specified in the study protocol. Visit 7 includes the final post-intervention assessment and the planned final intervention contact. HERDA is delivered alongside standard psychiatric care, which continues throughout the study period. The control group receives standard psychiatric care according to the study protocol.
HERDA uses culturally adapted educational materials, including Banjar-language audiovisual education and electronic flipbooks.
Intervention fidelity will be monitored throughout the HERDA intervention period as part of study quality assurance. Before intervention delivery, pharmacist counselors will undergo training and simulation to support standardized intervention delivery. Standardized pharmacist session logbooks, session checklists, supervision, and random internal audits will be used to document and monitor intervention implementation. Recorded indicators will include completion of scheduled intervention contacts, counseling duration, adherence to the HERDA protocol, delivery of applicable core counseling components, appropriate use of the Clinical Decision Matrix and Transtheoretical Model (TTM), use of educational materials when indicated, action planning, follow-up arrangements, patient understanding of key counseling messages, and session documentation.
Each applicable intervention component will be classified as delivered according to protocol, partially delivered, not delivered according to protocol, or not applicable. Safety-protocol compliance, protocol deviations, reasons for incomplete or modified sessions, and corrective actions, where applicable, will be documented separately. Periodic supervision and refresher training will be provided when needed to support consistent intervention delivery. Process evaluation data will be summarized descriptively to characterize intervention delivery and implementation throughout the study period. These monitoring procedures are intended to assess intervention implementation and are not measures of patient medication adherence or evidence of medication ingestion.
As a supplementary process evaluation, the acceptability and implementation of HERDA will also be explored after completion of the intervention through focus group discussions (FGDs) with pharmacist counselors, in-depth interviews with patients and family members, and a satisfaction questionnaire, as specified in the study procedures. Evaluation domains will include perceived benefits, satisfaction, experiences of receiving or delivering the intervention, implementation challenges, and recommendations for improvement. Qualitative data will be analyzed thematically, while questionnaire findings will be summarized descriptively. These findings will be used to characterize intervention acceptability and implementation and to inform interpretation of the study findings. They will be analyzed and interpreted separately from the randomized comparison of clinical and behavioral outcomes and will not constitute formal trial outcome measures.
This randomized controlled trial evaluates whether adding the HERDA pharmacist-led, culturally adapted intervention to standard psychiatric care improves medication adherence among outpatients with depression compared with standard psychiatric care alone. The study is intended to contribute evidence on the implementation of structured, culturally responsive pharmaceutical care for people receiving treatment for depression in Indonesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a two-arm, parallel-group randomized controlled trial involving 72 adult outpatients with depressive disorders at RSJ Sambang Lihum, Indonesia. Participants are randomized 1:1, stratified by depression severity and sex, to receive either HERDA plus usual psychiatric care or usual psychiatric care alone. HERDA is a pharmacist-led, culturally adapted intervention delivered through seven face-to-face and telephone contacts over four months. Outcomes are assessed at baseline and scheduled follow-up visits. Outcome assessors are blinded to group allocation, whereas intervention pharmacists are unblinded.
| Arm | Type | Receives |
|---|---|---|
| HERDA Intervention Group | Experimental | Behavioral: HERDA Pharmacist-Led Culturally Adapted InterventionParticipants receive the HERDA pharmacist-led, culturally adapted intervention in addition to standard psychiatric care. The intervention consists of seven planned contacts over approximately four months, combining face-to-face sessions and telephone contacts, delivered by trained pharmacists according to the study protocol. |
| Usual Care Group | No intervention | –Participants receive standard psychiatric care according to the study protocol, without the additional HERDA pharmacist-led intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 18 years or older.
- A clinical diagnosis of depressive disorder based on DSM-5 criteria, as documented in the medical record.
- Currently prescribed oral antidepressant medication.
- Able to understand study information and communicate in Bahasa Indonesia or Banjar.
- Able to use an Android mobile phone.
Key exclusion criteria (5 listed)
- Organic brain disorders or intellectual disabilities that impair the ability to understand study information, provide informed consent, or participate in study procedures.
- Severe comorbid conditions that may interfere with safe participation, including psychotic disorders, substance addiction, severe stroke, severe heart disease, severe diabetes-related complications, or other severe chronic conditions deemed unsuitable for participation by the treating physician.
- Inability to understand the study materials or hearing impairment that prevents effective communication or completion of study assessments.
- Any other condition that, according to the study protocol and clinical assessment, prevents safe participation in the intervention or completion of outcome assessments.
- Eligible outpatients will be screened before enrollment. Written informed consent will be obtained before any study-specific procedures are performed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HERDA Pharmacist-Led Culturally Adapted InterventionHERDA is a structured pharmacist-led, culturally adapted behavioral intervention designed to improve medication adherence among outpatients with depression. It integrates Brief Counseling 5A, the Transtheoretical Model (TTM) to tailor counseling to participants' readiness to change, pharmaceutical care, culturally adapted psychoeducation, and a predefined safety pathway for suicide-related concerns. The intervention is delivered by trained pharmacists through seven planned contacts over approximately four months, comprising face-to-face sessions and telephone contacts. Educational materials include Banjar-language audiovisual content and electronic flipbooks. Family or caregiver engagement is included when appropriate and with participant consent. HERDA is delivered in addition to standard psychiatric care and does not replace prescribed treatment or clinical assessment. | Behavioural | HERDA Intervention Group |
Primary outcome
Medication Adherence Measured by MARS-5
Time frame: Day 0 (baseline), Day 30, Day 60, and Day 120.
Medication adherence to antidepressants will be assessed using the five-item Medication Adherence Rating Scale (MARS-5). Each item is scored from 1 (always) to 5 (never), with higher scores indicating better adherence. The total score is the sum of all five items, ranging from 5 to 25. Adherence will be classified as adherent (total score ≥23; coded as 2) or non-adherent (total score <23; coded as 1), according to the study's prespecified operational definition.
Medication Adherence Measured by Pill Count
Time frame: Day 0 (baseline), Day 30, Day 60, and Day 120.
Medication adherence to antidepressants will be assessed by pill count. Adherence (%) will be calculated as [(tablets available for use during the assessment interval - tablets remaining at the end of the interval) / (prescribed tablets per day × number of days in the interval)] × 100%. Participants will be classified as adherent (80%-100%; coded 2) or non-adherent (<80%; coded 1), according to the study's prespecified criteria. Baseline pill count at V1 (Day 0) will document the initial medication supply. Adherence will be assessed over intervals ending at V3 (Day 30), V5 (Day 60), and V7 (Day 120). Dispensing records, early refills, and carryover tablets will be reconciled to account for available medication and prevent double-counting.
4 secondary outcomes
Depressive Symptom Severity Measured by PHQ-9
Time frame: Day 0 (baseline) and Day 120.
Self-Stigma Measured by the Self-Stigma Scale-Short (SSS-S)
Time frame: Day 0 (baseline) and Day 120.
Suicide Risk Assessed Using the MINI ICD-10 Suicidality Module
Time frame: Day 0 (baseline) and Day 120.
Medication-Related Health Behavior
Time frame: Day 0 (baseline), Day 30, Day 60, and Day 120.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- BackgroundAriyani H, Wiedyaningsih C, Prabandari YS. Pharmacists' roles and barriers in supporting psychiatric medication adherence: An interprofessional qualitative study. Pharmacy Practice. 2026;24(2):1-21.
- BackgroundAriyani H, Wiedyaningsih C, Prabandari RAYS, Idaiani S. Pharmacist intervention to improve medication adherence in patients with depressive disorder: A scoping review. Pharmacia. 2026;73:e178613.
- Individual participant dataSharing planned: Undecided. The decision regarding individual participant data (IPD) sharing has not yet been finalized. This study collects sensitive information on depression, antidepressant medication adherence, self-stigma, and suicide risk. The feasibility of sharing de-identified IPD will be reviewed after considering the research ethics approval, informed consent provisions, applicable data protection requirements, and institutional policies. Any future data-sharing plan will specify the data to be shared, access criteria, timing, and procedures for protecting participant confidentiality. No commitment to share IPD has been made at this stage.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chairun Wiedyaningsih principal investigator
Gadjah Mada University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HERDA Pharmacist-Led Culturally Adapted Intervention in people with Depression, run by Gadjah Mada University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Adherence Measured by MARS-5 (time frame: Day 0 (baseline), Day 30, Day 60, and Day 120.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07915427, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026; AzTrials last refreshed its copy on 4 Nov 2026.